Merck KGaA has entered into a collaborative agreement with Remepy to develop integrated “hybrid drugs” that merge pharmacological treatments with digital therapeutic software to boost medical efficacy.
The partnership will initially target Merck’s expanding rare tumor portfolio. This initiative aligns with the FDA’s 2023 PDURS (Prescription Drug Use-Related Software) framework, which provides a pathway for pharmaceutical companies to include digital components—such as specialized apps—on a drug’s official labeling, provided they demonstrate clinical utility.
Remepy’s approach involves using AI-driven mobile platforms to deliver evidence-based interventions in motor, physical, and cognitive domains. Research conducted by the startup indicates that digital-behavioral protocols can influence physiological biomarkers, suggesting a synergistic effect when used alongside traditional medication.
While the primary focus starts with oncology, Remepy is also advancing internal programs for Parkinson’s disease and maternal health. According to leadership at Remepy, the integration of software into the pharmaceutical ecosystem allows manufacturers to enhance the therapeutic impact of their products and differentiate their offerings in an increasingly digital healthcare landscape.
Source: https://pharmaphorum.com/news/merck-partners-remepy-pdurs-focused-alliance